Sedana Medical (SEDANA) Q4 2025 earnings summary

Executive summary

• Achieved first-time positive EBITDA in ex-US business (3% FY, 8% Q4), marking a turnaround from prior losses and meeting 2025 financial targets.

• Full-year net sales reached SEK 200.2 million, up 16% year-over-year at constant exchange rates, with Q4 sales at an all-time high of SEK 52 million.

• US pivotal trials met all primary endpoints, with FDA Fast Track Designation, Early Access Program approval, and positive pre-NDA meeting confirming data adequacy.

• Strategic focus on commercial execution, cost discipline, and targeted investments in high-growth markets, including restructuring headquarters post-COVID-19.

• Set new 2026 target for mid-to-high single-digit ex-US EBITDA and approaching group-level profitability.

Financial highlights

• Q4 net sales: SEK 51.8 million, up 5% year-over-year (11% FX-adjusted); full-year net sales: SEK 200.2 million, up 16% at constant FX.

• Q4 gross margin: 73% (up from 69%); full-year gross margin: 71%.

• Q4 EBITDA at group level: SEK 0.1 million (0.1% margin); ex-US Q4 EBITDA: SEK 4.0 million (8% margin).

• Year-end cash balance: SEK 91 million; Q4 cash flow from operations: SEK -5.2 million; total Q4 cash flow: SEK -19.1 million.

• Full-year EBITDA: SEK -10.1 million (vs. -30.6 million prior year); ex-US EBITDA: SEK 5.9 million (3% margin).

Outlook and guidance

• Expects ex-US EBITDA to grow to mid- to high-single-digit positive range in 2026 and approach group-level break-even.

• NDA submission for US approval planned mid-2026; potential US launch in 2027, depending on FDA review timeline.

• Sufficient financing projected for US approval; long-term target: EBITDA margin around 40% as US sales scale.